Senior Regulatory Affairs Specialist

Rhian_Convatec; Wales; Hybrid; GBP 45,000 - 60,000; Full time

Job summary

A leading medical technology firm located in Wales is seeking a Senior Regulatory Affairs Specialist to support global regulatory processes. The role requires a minimum of 5 years experience in medical device regulatory affairs and entails responsibilities such as preparing pre-marketing documentation, liaising with project teams, and ensuring compliance for infusion care devices. This position offers a hybrid working model and opportunities for personal growth and impact.

Benefits

Hybrid working model

Career development opportunities

Qualifications

• Minimum 5 years of experience in medical device regulatory affairs.
• Experience with Class I, II, III and sterile devices.
• Ability to conduct regulatory research and maintain compliance.

Responsibilities

• Act as RA lead for products under development.
• Prepare pre-marketing documentation for all regions.
• Review and approve labeling change requests.

Skills

Medical device regulatory affairs

ISO 13485:2016 knowledge

Project management

Analytical skills

Strong communication

Education

Bachelor's degree in Science, Engineering, Medical Technology or Nursing

Regulatory Affairs Certification (RAC)

Tools

Microsoft Office (Excel, Word, PowerPoint)

Adobe Acrobat

Job description

About Convatec

Pioneering trusted medical solutions to improve the lives we touch. Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide products and services in around 90 countries and guarantee improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion, and the company is a constituent of the FTSE 100 Index (LSE:CTEC).

Change is everywhere at Convatec. It’s transforming our business and helping us improve millions of lives. Join us on our journey to #ForeverCaring as a Senior Regulatory Affairs Specialist, and you’ll do the same.

Role Overview

The Senior Regulatory Affairs Specialist will support the global business concerning pre‑ and post‑market matters and ensure success by completing assigned tasks with minimal supervision for change control activities, product promotional activities, labeling reviews, product registration and listing database experience, global product registration requests, export/import activities, and post‑market actions.

Key Responsibilities

• Act as RA lead for products under development, liaising with project development teams, project managers, R&D, marketing, sales, operations and other QARAC associates. Ensure all RA requirements are included in the project plan and that timelines and regulatory pathways are understood and baked into the plan.

• Prepare pre‑marketing documentation for all regions (e.g., CE marking, 510(k)) according to agreed timelines.

• Prepare regulatory strategies, update technical files for MDR requirements and engage with global markets to ensure regulatory compliance.

• Maintain regulatory compliance for a range of infusion care devices via change assessment and management of associated documentation.

• Maintain renewals and up‑to‑date information for all appropriate registration and listing databases, supporting global regulatory teams.

• Complete regional RA requests and provide the requested regulatory documents.

• Review, assess and approve change control requests affecting the marketing of medical devices.

• Review and approve labeling change requests, advertising and promotional requests, field communications, etc., in accordance with CVT standards and industry guidance.

• Keep informed of new and revised regulatory requirements.

• Support as requested by supervisor with all other requests for information and documentation associated with regulatory laws and regulations.

• Complete all required training as well as maintain training plans and records.

• Maintain organization and security for all regulatory paper and electronic files.

• Develop, write, implement and maintain RA procedures.

Skills & Experience

• Minimum of 5 years of experience in medical device regulatory affairs.

• Understanding of the regulatory framework for medical devices.

• Experience with Class I, II, III and sterile devices.

• Familiarity with Class III and active medical devices highly desirable.

• Experience developing and implementing regulatory strategies for new product development projects is desirable.

• Understanding of ISO 13485:2016, including preparation and implementation of SOPs.

• Preferred: experience dealing directly with Notified Bodies, Competent Authorities and US FDA.

• Experience with electronic submission preferred.

• Experience with US/EU submissions.

• International regulatory affairs experience desirable.

• Self‑starter who can work independently.

• Good time‑management and problem‑solving skills.

• Strong interpersonal and collaborative skills.

• Ability to execute reactively and proactively in a timely manner.

• Ability to conduct thorough research of regulatory requirements and related issues to identify potential solutions and options.

• Ability to plan, manage, and execute project‑based tasks with tight deadlines.

• Strong analytical skills with good judgment.

• Demonstrated organizational skills.

• Strong oral and written communication skills.

• Proficiency with Microsoft Office (Excel, Word, PowerPoint), Adobe Acrobat, and internet‑based regulatory resources, Trackwise, Documentum, etc.

Education / Qualifications

• Minimum bachelor’s degree in Science, Engineering, Medical Technology or Nursing.

• Advanced degree and/or Regulatory Affairs Certification (RAC) preferred.

Travel Requirements

• Some business‑related travel may be required, depending on projects and local markets.

• Attendance at relevant training and development events is required.

• Some destinations may involve overnight or longer stays.

Working Conditions

• Hybrid working model.

Our transformation will change your career. You'll be pushed to think bigger, aim for excellence, and have your ideas heard. You'll be supported to bring them to life, faced with challenges yet provided with opportunities to make your biggest impact yet.

This is stepping outside of your comfort zone.

This is work that will move you.

#LI-AC2

#LI-Hybrid

Beware of scams online or from individuals claiming to represent Convatec.

A formal recruitment process is required for all our opportunities prior to any offer of employment, including an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email, or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [e-mail].

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means no one will be discriminated against because of race, religion, creed, color, national origin, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics, or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and view "Convatec Internal Career Site – Find Jobs". Thank you!